A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Alcohol Liver Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Zhujiang Hospital of Southern Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
(1) patients diagnosed with liver cirrhosis based on clinical-pathologic features including liver history and endoscopic or radiologic findings (the presence of clinical cirrhosis was adjudicated in a blinded fashion by two separate hepatology experts; to be included, both experts were required to agree on the presence of clinical cirrhosis) and (2) all patients with chronic liver disease were required to have evidence of clinical liver disease for at least 6 months and were required to have an identifiable etiology of liver disease, including alcohol-related liver diseases (based on a history of alcohol use disorder or a past history of alcohol consumption of greater than 2 ounces of ethanol per day for men or 1 ounce of ethanol per day for women (for greater than 10 years) with no other cause of liver disease identified), NAFLDs, viral hepatitis B or C (detected by HCV RNA or HBV DNA measurement) or autoimmune liver disease (based on international autoimmune scoring criteria).
Exclusion Criteria:
(1) individuals treated with antibiotics, probiotics or proton pump inhibitors within 1 month before sample collection; (2) any participant undergoing a gastrointestinal surgical procedure or colonoscopy within 6 months before sample collection; (3) any individual with uncontrolled infection; and (4) individuals with uncontrolled systolic blood pressure.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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ALD-related cirrhosis
This cohort consists of patients with alcohol-related liver cirrhosis, diagnosed based on clinical-pathological assessment with confirmation by two hepatologists.
All patients had chronic liver disease for ≥6 months with an established etiology (primarily alcohol-related, defined as >2 oz/day ethanol for men or >1 oz/day for women for >10 years).
Key exclusions include recent (within 1 month) use of antibiotics/probiotics/PPIs, recent (within 6 months) gastrointestinal procedures, and presence of uncontrolled infection or hypertension.
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An observational, non-interventional study design.
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health
This cohort consists of age- and sex-matched healthy controls recruited from a Health Checkup Center, with no clinically diagnosed chronic diseases.
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An observational, non-interventional study design.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fecal NOD2-stimulating activity, measured using a HEK-Blue-hNOD2 reporter cell assay.
Time Frame: Baseline (pre-treatment)
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To explore the potential of peptidoglycan fragments as screening or diagnostic biomarkers for alcohol-related liver disease.
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Baseline (pre-treatment)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Xiaolong He, xiaolong, Southern Medical University, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ZhujingGS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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